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EarCalm Spray

Active Ingredient:
acetic acid
Company:  
Dexcel Pharma Ltd See contact details
About Medicine
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Pharmacy
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 21 Oct 2024
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL14017/0310.

{printer} Print patient leaflet as text only

Earcalm Spray

PATIENT INFORMATION LEAFLET

EarCalm SPRAY

Acetic acid 2%

Please read right through this leaflet before you start using this medicine. This medicine is available without prescription, but you still need to use EarCalm carefully to get the best results from it.

  • Keep this leaflet you may need to read it again.
  • If you have any further questions, ask your pharmacist.
  • Do not use for more than 7 days.

In this leaflet:

1. What EarCalm does
2. Check before you use EarCalm
3. How to use EarCalm
4. Possible side effects
5. How to store EarCalm
6. Further information

1. What EarCalm does

EarCalm is used for the treatment of minor infections of the outer ear.

The active ingredient is acetic acid, an antibacterial agent that helps clear such infections.

2. Check before you use EarCalm
Do not use EarCalm:
  • if you have ever had an allergic reaction to acetic acid or any of the other ingredients (listed in Section 6)
  • if you are under 12 years
  • anywhere other than in the ear. Do not inhale in the mouth or nose or spray near the eyes.

Take special care with EarCalm
  • If you have a perforated eardrum, or if you think you may have, consult your doctor before you use this medicine.
  • Stop treatment and call your doctor:
    • if you get any pain
    • if symptoms worsen or do not improve within 48 hours
    • if hearing is affected.
  • Do not use for more than 7 days.

3. How to use EarCalm
Before using a new bottle of EarCalm
  • Shake well before use
  • Press the pump down several times until you get a fine spray
  • Make sure you do not point the nozzle at yourself or someone else
  • The bottle is now ready for use
  • Each time the pump is pressed down one measured dose will be delivered
  • If you have not used EarCalm for more than a week, press the pump a few times until you get a fine spray again, and then follow the instructions above.

For external use only.

Using EarCalm
  • Shake well before use
  • Place the nozzle tip gently into your ear
  • Press the pump once to deliver the measured dose
  • Spray one measured dose into each affected ear at least three times a day (morning, evening and after swimming, showering or bathing), or as directed by your doctor/pharmacist
  • Leave at least 2 to 3 hours between doses
  • Continue treatment until two days after symptoms have disappeared, but no longer than 7 days
  • If you forget to use EarCalm do not worry. Use it as soon as you remember then go on as before
  • The nozzle tip must be in place when you use the spray. You can remove it for cleaning but always click it back into place afterwards
  • After use, wipe the nozzle tip with a tissue to remove any ear wax residue.

4. Possible side effects

Like all medicines, EarCalm can have side effects, but not everybody gets them:

  • sensitivity or allergy. If this happens, stop using the spray.
  • temporary stinging or a burning sensation for the first few days of treatment

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store EarCalm

Keep out of the reach and sight of children.

Do not use this medicine after the ‘EXP’ date shown on the pack.

Do not store above 25ºC.

Keep container upright in the outer carton.

Use within one month of first use.

6. Further information

Active ingredient 2% w/w Acetic Acid (glacial).

Other ingredients Macrogol stearyl alcohol, stearyl alcohol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), purified water.

EarCalm is supplied in packs containing 5ml as an aqueous suspension. The spray is non-pressurised and does not contain CFCs.

The marketing authorisation holder is

Dexcel®-Pharma Ltd.
7 Sopwith Way
Drayton Fields
Daventry
Northamptonshire
NN11 8PB
UK

and all enquiries should be sent to this address.

The manufacturer is

Purna Pharmaceuticals NV
Rijksweg 17
2870 Puurs
Belgium

This leaflet was last revised in February 2024.

EarCalm is a Trade Mark of Dexcel®-Pharma Ltd.

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Dexcel Pharma Ltd
Company image
Address
7, Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
Telephone
+44 (0)1327 312 266
Fax
+44 (0)1327 312 262
Medical Information e-mail
[email protected]
Medical Information Direct Line
+44 (0) 1748 828 784
WWW
http://www.dexcelpharma.com
Out of Hours Telephone
+44 (0) 1748 828 784
E-mail
[email protected]